Difficult IntubationNCT04264338
Thyromental Height Test as a Predictor of Difficult Airway:
An observational study of Difficult Intubation, run by Cairo University.
Trial summary
Anesthesia is increasingly safe. Major complications of airway management are no more common but still the most life-threatening condition amongst anesthesia practice and even medicine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Thyromental height test
- How many people
- 612 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2020to 20 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients, aged from 18-60 years old, with ASA physical status I \& II who will undergo elective surgical procedures under general anesthesia using endotracheal intubation using conventional laryngoscopy.
Who may be able to join
- ASA physical status I \& II
- Scheduled for elective surgical procedures under general anesthesia using endotracheal with conventional laryngoscopy
Who cannot join
- Patients with a body mass index >35 kg/m2.
- Patients with neuromuscular disorders, craniofacial abnormalities, and abnormal dentition.
- Patients with airway diseases e.g cancer larynx or tongue, uncooperative patients, those who will need awake intubation and patients who will undergo emergency operations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Validity of the Thyromental Height Test as a Predictor of the Difficult Airway: A Prospective Comparative Study With Interincisor Distance, Thyromental Distance, Sternomental Distance & Modified Mallampati Test
Anesthesia is increasingly safe. Major complications of airway management are no more common but still the most life-threatening condition amongst anesthesia practice and even medicine. Thyromental height test (TMHT) is an objective measure of the height between the anterior borders of the mentum and thyroid cartilage, measured while the patient is lying supine with the mouth closed. This study was designed to assess the validity of the TMHT as a single objective predictor for difficult laryngoscopy and to be compared to other objective measures.
- Conditions
- Difficult Intubation
- Being tested
- Thyromental height test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyromental height testDiagnostic test
Assessment of difficult airway
What is being measured
The primary outcome is the main question the study is designed to answer.
validity of the TMHT in prediction of difficult airway in patients undergoing general anesthesia for elective surgeries using area under ROC curve for the TMHT.
Measured: baseline (before induction of general anesthesia)
Validity of TMHT in comparison with that of Modified Mallampati test (MMT) in prediction of difficult airway by comparing area under ROC curve for both tests.
Measured: baseline (before induction of general anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start20 Feb 2020 (estimated)
- Primary completion20 Aug 2020 (estimated)
- Study completion20 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264338
- Sponsor's protocol ID
- MD-246-2019
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of the Thyromental Height Test as a Predictor of the Difficult Airway: A Prospective Comparative Study With Interincisor Distance, Thyromental Distance, Sternomental Distance & Modified Mallampati Test
- ClinicalTrials.gov ID
- NCT04264338
- Acronym / sponsor ID
- MD-246-2019
- Conditions
- Difficult Intubation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (estimated)
- Primary completion
- 20 Aug 2020 (estimated)
- Study completion
- 20 Oct 2020 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anesthesia is increasingly safe. Major complications of airway management are no more common but still the most life-threatening condition amongst anesthesia practice and even medicine. Thyromental height test (TMHT) is an objective measure of the height between the anterior borders of the mentum and thyroid cartilage, measured while the patient is lying supine with the mouth closed. This study was designed to assess the validity of the TMHT as a single objective predictor for difficult laryngoscopy and to be compared to other objective measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients, aged from 18-60 years old, with ASA physical status I \& II who will undergo elective surgical procedures under general anesthesia using endotracheal intubation using conventional laryngoscopy.
Key inclusion criteria (2 listed)
- ASA physical status I \& II
- Scheduled for elective surgical procedures under general anesthesia using endotracheal with conventional laryngoscopy
Key exclusion criteria (3 listed)
- Patients with a body mass index >35 kg/m2.
- Patients with neuromuscular disorders, craniofacial abnormalities, and abnormal dentition.
- Patients with airway diseases e.g cancer larynx or tongue, uncooperative patients, those who will need awake intubation and patients who will undergo emergency operations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyromental height testAssessment of difficult airway | Diagnostic test | – |
Primary outcome
validity of the TMHT in prediction of difficult airway in patients undergoing general anesthesia for elective surgeries using area under ROC curve for the TMHT.
Time frame: baseline (before induction of general anesthesia)
Validity of TMHT in comparison with that of Modified Mallampati test (MMT) in prediction of difficult airway by comparing area under ROC curve for both tests.
Time frame: baseline (before induction of general anesthesia)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Difficult Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Intubation, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abeer Ahmed, MD (01005244590, abeer_ahmed@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity of the TMHT in prediction of difficult airway in patients undergoing general anesthesia for elective surgeries using area under ROC curve for the TMHT. (time frame: baseline (before induction of general anesthesia)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.